# Cardiolite (TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE) by SHINE SPECT USA, LLC: new human prescription drug listing

**Launch Signal Score:** 80/100

| Field | Value |
|---|---|
| Product | Cardiolite |
| Generic name | TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE |
| NDC | 87333-001 |
| Labeler | SHINE SPECT USA, LLC |
| Product type | HUMAN PRESCRIPTION DRUG |
| Approval pathway | NDA |
| Application number | NDA019785 |
| Dosage form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route | INTRAVENOUS |
| Active ingredients | TETRAKIS(2-METHOXYISOBUTYLISOCYANIDE)COPPER(I) TETRAFLUOROBORATE 1 mg/mL |
| Marketing start | 2026-09-10 |
| Package configurations | 2 |

## Why this score
- Prescription or biologic product.
- Brand or biologic launch.
- Injectable: hospital and 503B relevance.

Source: U.S. FDA National Drug Code (NDC) Directory via openFDA (https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=87333-001). Last refreshed: 2026-11-04T18:12:05.743Z.
Listing data comes from the FDA NDC directory via openFDA; a listing is not an FDA approval or endorsement and may be updated or withdrawn. Informational only; not medical advice.